AzTrials
AzTrials

Acute Myocardial InfarctionPhase 2NCT02108262

A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

A Phase 2 study testing CSL112 in people with Acute Myocardial Infarction, run by CSL Behring at 189 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
CSL112
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,267 participants
Where
189 sitesin 16 countries
Study dates
Aug 2014to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.

Who cannot join

  • Ongoing hemodynamic instability
  • Evidence of hepatobiliary disease
  • Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
  • Evidence of unstable renal function
  • History of acute kidney injury after previous exposure to an intravenous contrast agent.
  • Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
  • Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

Trial locations and contacts

189 sites in 16 countries.

189 sites in 16 countries

United States48 sites

  • Study Site 16208

    Alexandria, Louisiana, 71301

  • Study Site 16015

    Amarillo, Texas, 79106

  • Study Site 16144

    Atlanta, Georgia, 30322

  • Study Site 16062

    Auburn, Maine, 04210

  • Study Site 16031

    Baltimore, Maryland, 21215

  • Study Site 16079

    Bangor, Maine, 04401

  • Study Site 16101

    Birmingham, Alabama, 35211

  • Study Site 16112

    Boise, Idaho, 83712

  • Study Site 16170

    Bridgeport, Connecticut, 06606

  • Study Site 16033

    Brooklyn, New York, 11215

  • Study Site 16174

    Buffalo, New York, 14215

  • Study Site 16047

    Cincinnati, Ohio, 45219

  • Study Site 16148

    Clearwater, Florida, 33756

  • Study Site - 16168

    Concord, California, 94520

  • Study Site 16168

    Concord, California, 94520

  • Study Site 16099

    Dallas, Texas, 75216

  • Study Site 16135

    Danbury, Connecticut, 06810

  • Study Site 16028

    Detroit, Michigan, 48202

  • Study Site 16056

    Durham, North Carolina, 27705

  • Study Site 16201

    Elizabeth City, North Carolina, 27909

  • Study Site 16179

    Elkhart, Indiana, 46514

  • Study Site 16060

    Evanston, Illinois, 60201

  • Study Site 16202

    Greeneville, Tennessee, 37745

  • Study Site 16039

    Greenwood, South Carolina, 29646

  • Study Site 16026

    Hershey, Pennsylvania, 17033

  • Study Site 16014

    High Point, North Carolina, 27262

  • Study Site 16078

    Huntsville, Alabama, 35801

  • Study Site 16102

    Indianapolis, Indiana, 46290

  • Study Site 16003

    Jacksonville, Florida, 32209

  • Study Site 16100

    Lancaster, Pennsylvania, 17604

  • Study Site 16088

    Lexington, Kentucky, 40504

  • Study Site 16004

    Lexington, Kentucky, 40536

  • Study Site 16130

    Littleton, Colorado, 80120

  • Study Site 16016

    Louisville, Kentucky, 40202

  • Study Site 16211

    Minneapolis, Minnesota, 55407

  • Study Site 16213

    New York, New York, 10029

  • Study Site 16061

    Petoskey, Michigan, 49770

  • Study Site 16017

    Philadelphia, Pennsylvania, 19104

  • Study Site 16018

    Rapid City, South Dakota, 57701

  • Study Site 16038

    Richmond, Virginia, 23298

  • Study Site 16147

    Sacramento, California, 95819

  • Study Site 16234

    Saint Paul, Minnesota, 55102

  • Study Site 16022

    Torrance, California, 90502

  • Study Site 16063

    Tupelo, Mississippi, 38801

  • Study Site 16166

    Wausau, Wisconsin, 54401

  • Study Site 16025

    West Des Moines, Iowa, 50266

  • Study Site 16241

    Wichita Falls, Texas, 76301

  • Study Site 16024

    Winston-Salem, North Carolina, 27157

Other trials in United States

Bulgaria19 sites

  • Study Site 12005

    Blagoevgrad, 2700

  • Study Site 12008

    Burgas, 8000

  • Study Site 12006

    Dobrich, 9300

  • Study Site 12021

    Haskovo, 6300

  • Study Site 12009

    Pazardzhik, 4400

  • Study Site 12019

    Pazardzhik, 4400

  • Study Site 12016

    Pleven, 5800

  • Study Site 12014

    Plovdiv, 4002

  • Study Site 12018

    Plovdiv, 4002

  • Study Site 12017

    Sandanski, 2800

  • Study Site 12003

    Sofia, 1233

  • Study Site 12001

    Sofia, 1309

  • Study Site 12004

    Sofia, 1407

  • Study Site 12012

    Sofia, 1407

  • Study Site 12010

    Sofia, 152

  • Study Site 12013

    Sofia, 1750

  • Study Site 12011

    Varna, 9010

  • Study Site 12002

    Veliko Tarnovo, 5000

  • Study Site 12007

    Yambol, 8600

Other trials in Bulgaria

Czechia16 sites

  • Study Site 14010

    Brno, 625 00

  • Study Site 14006

    Brno, 656 91

  • Study Site 14004

    Hradec Králové, 500 05

  • Study Site 14012

    Jablonec nad Nisou, 466 60

  • Study Site 14011

    Jihlava, 586 33

  • Study Site 14016

    Kolín, 280 00

  • Study Site 14017

    Náchod, 547 01

  • Study Site 14007

    Ostrava, 708 52

  • Study Site 14003

    Pardubice, 532 03

  • Study Site 14002

    Prague, 100 34

  • Study Site 14001

    Prague, 128 08

  • Study Site 14015

    Prague, 128 08

  • Study Site 14009

    Prague, 150 06

  • Study Site 14008

    Praha 4 - Krc, 140 59

  • Study Site 14014

    Teplice, 415 01

  • Study Site 14005

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Netherlands12 sites

  • Study Site 21001

    Alkmaar, 1815 JD

  • Study Site 21006

    Amsterdam, 091 AC

  • Study Site 21013

    Amsterdam, 1081 HV

  • Study Site 21016

    Amsterdam, 1105 AZ

  • Study Site 21004

    Ede, 6716 RP

  • Study Site 21014

    Leeuwarden, 8934 AD

  • Study Site 21003

    Nieuwegein, 3435 CM

  • Study Site 21008

    Nijmegen, 6525 EC

  • Study Site 21009

    Rotterdam, 3079 DZ

  • Study Site 21010

    Sneek, 8601 ZK

  • Study Site 21015

    Tilburg, 5042 AD

  • Study Site 21011

    Venlo, 5912 BL

Other trials in Netherlands

Spain12 sites

  • Study Site - 23012

    A Coruña, La Coruna, 15006

  • Study Site - 23005

    Barcelona, 08003

  • Study Site - 23002

    Barcelona, 08023

  • Study Site - 23001

    Barcelona, 08036

  • Study Site - 23010

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study Site - 23003

    Madrid, 28007

  • Study Site - 23013

    Madrid, 28034

  • Study Site - 23004

    Madrid, 28040

  • Study Site - 23007

    Málaga, 29010

  • Study Site - 23006

    Santiago de Compostela, La Coruna, 15706

  • Study Site - 23009

    Tarragona, 43007

  • Study Site - 23011

    Valencia, 46010

Other trials in Spain

Germany11 sites

  • Study Site 17005

    Berlin, Berin, 10249

  • Study Site 17003

    Berlin, 10117

  • Study Site 17009

    Berlin, 10967

  • Study Site 17002

    Berlin, 12351

  • Study Site 17014

    Franfurt, Hesse, 65929

  • Study Site 17001

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study Site 17006

    Hamburg, 20246

  • Study Site 17012

    Hanover, Lower Saxony, 30625

  • Study Site 17007

    Lüdenscheid, North Rhine-Westphalia, 58509

  • Study Site 17010

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Study Site 17011

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Poland11 sites

  • Study Site - 22015

    Gdansk, 80-952

  • Study Site - 22010

    Grodzisk Mazowiecki, 05-825

  • Study Site - 22012

    Inowrocław, 88-10

  • Study Site 22009

    Kielce, 25-736

  • Study Site - 22007

    Krakow, 31-202

  • Study Site - 22014

    Lodz, 91-347

  • Study Site - 22013

    Starogard Gdański, 83-200

  • Study Site - 22006

    Wałbrzych, 58-309

  • Study Site - 22008

    Warsaw, 01-211

  • Study Site - 22016

    Wejherowo, 84-200

  • Study Site - 22005

    Wroclaw, 50-981

Other trials in Poland

Canada9 sites

  • Study Site - 13003

    Edmonton, Alberta, T5H 3V9

  • Study Site - 13002

    Edmonton, Alberta, T6G 2B7

  • Study Site - 13008

    London, Ontario, N6A 5A5

  • Study Site - 13014

    Montreal, Quebec, H2W 1T8

  • Study Site - 13010

    Newmarket, Ontario, L3Y 2P7

  • Study Site - 13017

    Penticton, British Columbia, V2A 3G6

  • Study Site - 13007

    Québec, G1V 4G5

  • Study Site - 13019

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study Site - 13012

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Israel9 sites

  • Study Site 19010

    Ashkelon, 7830604

  • Study Site 19006

    Beersheba, 8410101

  • Study Site 19005

    Haifa, 3109601

  • Study Site 19004

    Holon, 5822012

  • Study Site 19003

    Jerusalem, 91120

  • Study Site 19007

    Jerusalem, 9124001

  • Study Site 19002

    Nahariya, 2210001

  • Study Site 19009

    Ramat Gan, 5262000

  • Study Site 19008

    Safed, 13100

Other trials in Israel

Italy9 sites

  • Study Site 20009

    Benevento, 82100

  • Study Site 20003

    Legnano, Milano, 20025

  • Study Site 20002

    Magenta, Milano, 20013

  • Study Site 20011

    Naples, 80131

  • Study Site 20007

    Rimini, 47923

  • Study Site 20012

    Roma, 00189

  • Study Site 20008

    Rozzano, Milano, 20089

  • Study Site 20001

    Terni, 05100

  • Study Site 20006

    Udine, 33100

Other trials in Italy

Hungary8 sites

  • Study Site 18008

    Budapest, 1023

  • Study Site 18001

    Budapest, 1122

  • Study Site 18005

    Budapest, 1134

  • Study Site 18002

    Győr, 9024

  • Study Site 18007

    Nyíregyháza, 4400

  • Study Site 18003

    Pécs, 7624

  • Study Site 18009

    Szeged, 6720

  • Study Site 18006

    Szolnok, 5000

Other trials in Hungary

France6 sites

  • Study Site - 25008

    Nantes, Loire Antlantique, 44093

  • Study Site - 25002

    Paris, Paris, 75571

  • Study Site - 25001

    Paris, 75013

  • Study Site - 25004

    Pau, Pyrenees Atlantiques, 64046

  • Study Site - 25003

    Pessac, Gironde, 33604

  • Study Site - 25005

    Toulouse, Haute Garonne, 31076

Other trials in France

United Kingdom6 sites

  • Study Site - 24004

    Basildon, Essex, SS16 5NL

  • Study Site - 24006

    Clydebank, Dunbartonshire, G81 1DY

  • Study Site - 24010

    Leicester, Leicestershire, LE3 9QP

  • Study Site - 24003

    London, Greater London, E2 9JX

  • Study Site - 24009

    Newcastle upon Tyne, Tyne & Wear, NE7 7DN

  • Study Site 24005

    Romford, Essex, UM7 0AG

Other trials in United Kingdom

Australia5 sites

  • Study Site 10005

    Adelaide, South Australia, 5000

  • Study Site 10006

    Epping, Victoria, 3076

  • Study Site 10007

    Geelong, Victoria, 3220

  • Study Site 10002

    Herston, Queensland, 4029

  • Study Site 10012

    Woodville South, South Australia, 5011

Other trials in Australia

Denmark5 sites

  • Study Site 15001

    Aalborg, 9100

  • Study Site 15005

    Esbjerg, 6700

  • Study Site 15002

    Hellerup, 2900

  • Study Site 15004

    Hvidovre, 2650

  • Study Site 15003

    Odense, 5000

Other trials in Denmark

Austria3 sites

  • Study Site 11004

    Innsbruck, 6020

  • Study Site 11002

    Vienna, 1090

  • Study Site 11001

    Vienna, 1160

Other trials in Austria

About this study

Official title: A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

Being tested
CSL112, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSL112Biological

    CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.

  • PlaceboBiological

    0.9% weight/volume sodium chloride solution (ie, normal saline)

Study groups in NCT02108262
Study groupRoleWhat they receive
CSL112 - low doseExperimentalCSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.
Receives: Biological: CSL112
CSL112 - high doseExperimentalCSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.
Receives: Biological: CSL112
PlaceboPlacebo comparatorPlacebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Participants With Clinically Important Change in Drug-induced Liver Injury

    A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement.

    Measured: From baseline (before first infusion) to Day 29.

  2. Percent of Participants With Clinically Important Change in Renal Status

    A clinically important change in renal status is defined as a serum creatinine (Cr) increase to ≥ 1.5 x the baseline value that is confirmed upon repeat measurement.

    Measured: From baseline (before first infusion) to Day 29.

Secondary outcomes (61)

  1. The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)

    The MACE is a 4-component composite comprised of the time to the first of the following events: CV death, nonfatal myocardial infarction, ischemic stroke (non-hemorrhagic), and hospitalization for unstable angina.

    Measured: From the start of the first infusion up to approximately 382 days

  2. Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants

    Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112

    Measured: Before first infusion and end of first infusion

  3. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants

    Measured: Before first infusion and end of fourth infusion

  4. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function

    apoA-I and PC are analytes of CSL112

    Measured: Before first infusion and end of first infusion

  5. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function

    apoA-I and PC are analytes of CSL112

    Measured: Before first infusion and end of fourth infusion

  6. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment

    apoA-I and PC are analytes of CSL112

    Measured: Before first infusion and end of first infusion

  7. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment

    apoA-I and PC are analytes of CSL112

    Measured: Before first infusion and end of fourth infusion

  8. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  9. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  10. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  11. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  12. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  13. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Cmax is the maximal plasma concentration.

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  14. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the first infusion

  15. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the fourth infusion

  16. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the first infusion

  17. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the fourth infusion

  18. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the first infusion

  19. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Tmax is time to maximal plasma concentration

    Measured: Before and for 7 days after the fourth infusion

  20. Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  21. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  22. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  23. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  24. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  25. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline [AUC0 - last]

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  26. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  27. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  28. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  29. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  30. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  31. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    AUC from baseline to time point t (AUC0-t)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  32. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  33. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  34. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  35. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  36. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  37. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    AUC0-∞ is plasma area under the curve (AUC0-infinity)

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  38. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  39. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  40. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  41. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  42. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  43. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  44. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  45. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  46. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  47. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  48. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  49. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  50. Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  51. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  52. Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  53. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  54. Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after first infusion

  55. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

    Measured: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

  56. Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions

    The overall percentage of subjects:

    • with adverse events (AEs), including local tolerability events, that begin during or within 1 hour of an infusion; or
    • with AEs considered to be causally related to the test product; or
    • who experience an AE for which the incidence rate in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.

    Measured: From the start of first infusion, up to approximately Day 382

  57. Percent of Participants With Any Adverse Event (AE)

    Measured: From the start of first infusion, up to approximately Day 382

  58. Percent of Participants Who Experience Bleeding Events

    The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)

    Measured: From the start of first infusion, up to approximately Day 112

  59. Change From Baseline in Serum Antibodies to CSL112 and apoA-I

    Measured: Before first infusion, up to approximately Day 112

  60. Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19

    Measured: Study Day 112

  61. Number of Participants With Parvovirus B19 DNA in Serum

    Measured: Study Day 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02108262
Sponsor's protocol ID
CSLCT-HDL-12-77
Other IDs
2013-003458-26
Status last verified
Feb 2021
First submitted
31 Mar 2014
Last updated
15 Mar 2021
Data monitoring committee
Yes

Publications

  • Didichenko SA, Velkoska E, Navdaev AV, Greene BH, Lorkowski SW, Duffy D, Mears SJ, Wright SD, Gibson CM, Smith JD, Kingwell BA. CSL112 Infusion Rapidly Increases APOA1 Exchange Rate via Specific Serum Amyloid-Poor HDL Subpopulations When Administered to Patients Post-Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2023 Jun;43(6):855-869. doi: 10.1161/ATVBAHA.122.318243. Epub 2023 Mar 30.

    PubMed 36994730

  • Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.

    PubMed 33217027

  • Michael Gibson C, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea DM, Deckelbaum LI, Merkely B, Zarebinski M, Ophuis TO, Harrington RA. Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. 2016 Dec 13;134(24):1918-1930. doi: 10.1161/CIRCULATIONAHA.116.025687. Epub 2016 Nov 15.

    PubMed 27881559

  • Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA. Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction. Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017. Epub 2016 Jul 5.

    PubMed 27659879

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CSL112 in people with Acute Myocardial Infarction, run by CSL Behring at 189 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 189 sites in United States, Bulgaria, Czechia, Netherlands, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants With Clinically Important Change in Drug-induced Liver Injury (time frame: From baseline (before first infusion) to Day 29.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02108262, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.

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